MR1436 - Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial

ICNARC require this Data Sharing Agreement to be extended for a further three years to allow retention of the data in line with ICNARC Standard Operating Procedures. There will be no further data provided by NHS Digital in the form of list cleaning reports, and no further patient information will be sent by ICNARC to NHS Digital. Final results of the trial are still to be written up, and data in the database is required to achieve this.

The POPPI (Provision of Psychological support to People in Intensive care) trial is funded by the National Institute for Health Research Health Services and Delivery Research Programme (funding reference 12/64/124). It is increasingly recognised that high numbers of critically ill patients develop longer-term psychological morbidity following a stay in the critical care unit.

Many critically ill patients suffer disturbing psychological symptoms, such as panic or hallucinations during their stay in the intensive care unit. Doctors believe that these frightening experiences are caused by the effects of illness, drugs, stressful treatments such as being on a breathing machine (ventilator), and by the alien environment of the intensive care unit. There is now strong evidence that these stressful experiences may trigger longer-term psychological problems for patients, such as post-traumatic stress disorder, severe depression and anxiety.

It can be difficult for intensive care nurses to recognise these symptoms. Most patients are unable to speak while they are on ventilators with a tube in their throat, while others may be withdrawn and unwilling to express how they feel. Many intensive care nurses also find it stressful to look after patients who are delirious or agitated, as they receive no special training in this type of care.

POPPI is a research study which aims to evaluate whether patients’ well-being is improved after a stay in the intensive care unit by using a complex intervention, which teaches nurses how to:

• provide a calm, therapeutic environment for critically ill patients

• detect psychological distress in critically ill patients

• provide stress support sessions to their more distressed patients

POPPI will evaluate the clinical effect of the complex intervention on patient-reported Post-Traumatic Stress Disorder symptom severity and other psychological morbidities and quality of life at six months; and on the cost-effectiveness in an integrated economic analysis. An integrated process evaluation understands the quality of the implementation of the intervention, and identify important factors to better understand how the intervention works.

The POPPI Study consists of two stages:

Stage one included a feasibility study and a pilot study. The feasibility study developed and tested the training course for intensive care nurses in two NHS hospitals. The pilot study, conducted in two different NHS hospitals, ensured the necessary processes/procedures were in place to proceed to stage two. Stage two was a randomised clinical trial conducted at 24 NHS hospitals throughout the UK to find out if psychological training for nurses improves patients’ well-being after a stay in the intensive care unit. Psychological training was provided to nurses in 12 intensive care units. Patients in these units were be compared with patients in the other 12 intensive care units where nurses did not receive psychological training.

Patients participating in the trial, are those who stayed over 48 hours in a participating critical care unit and received organ support (Level 3 care), recovering from their critical illness and have provided informed consent to be part of the trial. Participating patients were treated according to whether the critical care unit they were admitted to received the additional training or not. Patients surviving to six months are sent a follow-up questionnaire (which contains the primary outcome and some secondary outcomes for the trial). Data on patients’ survival status and GP code were requested from NHS Digital to ensure that no further contact was made by the POPPI trial with participants who have passed away; helping to ensure relatives were not caused undue stress by no longer appropriate contact. The database for the trial is locked, but needs to be retained for a period of 10 years in line with the ICNARC Standard Operating Procedures in case any requests to check or confirm the data are made from the Sponsor, ethics committee or individuals on the trial. Participating patients also provide informed consent to be contacted in the future, where relevant to the POPPI trial, or for their data to be shared anonymously with other researchers. Only data required to directly answer the trial questions, to assess safety, or to monitor the conduct of the trial are collected for the trial.

The objective for processing these data was to aid the follow-up of patients in the Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial.

Data obtained from NHS Digital was used only to ascertain whether patients taking part in the trial were still alive at six months (the follow-up time point for the POPPI trial). Where ICNARC found out that a patient had passed away, no contact with the participant was made - helping to ensure relatives were not caused undue stress by no longer appropriate contact.

ICNARC is the sole Data Controller for the data being requested from NHS Digital.

The Data Processors for the data being requested from NHS Digital are ICNARC, Babble Cloud (SUI) Limited and Exponential-E Ltd. Exponential-E Ltd manage ICNARC’s secure virtual data centre, providing storage but not accessing the data. Babble Cloud (SUI) Limited provide ICNARC’s end user IT support. Babble Cloud (SUI) Limited does not process the data but they do have the ability to access the data, therefore they have been listed as a Data Processor.

The project is funded by the NIHR Health Services & Delivery Research Programme (funding reference 12/64/124); the funder has no role in the conduct of the research. NIHR do not determine the aims and objectives of the study and therefore are not considered a Data Controller under this Agreement.

ICNARC is an independent health research charity which aims to help improve the quality of critical care through audit, research and education with, and in the interests of, patients and those who care for them. ICNARC requires data from NHS Digital for the purposes of these legitimate interests.

ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Specifically, data is processed under the following articles of the Data Protection Act 2018:

Article 6 (1) (f) Legitimate interests: the processing is necessary for your legitimate interests or the legitimate interests of a third party unless there is a good reason to protect the individual’s personal data which overrides those legitimate interests.

The data is required to be retained for a research project - and therefore ICNARC process the special category data (health data) under the following article of GDPR - Article 9 (2) (j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

Processing personal data is necessary for ICNARC's legitimate interests which are described in this agreement. The data to which access is requested are proportionate and necessary to achieve those interests. ICNARC have completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override the legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects' interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; pseudonymisation to minimise any risk of identifying individuals; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project.

ICNARC have assessed this against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that the requirements are met.

Primary outcomes:

To evaluate, Patient-reported PTSD symptom severity at six months and Incremental costs, quality adjusted life years and net monetary benefit

Secondary outcomes:

To compare: Days alive and free from sedation to day 30, Duration of critical care unit stay and Depression at six months.

Post traumatic Diagnostic Scale score of greater than 18 points at six months and Health-related quality of life at six months

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Patients providing informed consent to take part in the POPPI trial agreed for identifiable information to be collected about them. For patients reaching six months in the trial and who are believed to be alive, their date of birth, postcode, NHS number and patient ID number was provided to NHS Digital.

NHS Digital then linked these identifiers to national records and sent back a spread sheet confirming the latest status for each patient, and if relevant, the date of latest posting. This is known as a list cleaning report.

The General Practice (GP) code field was requested to facilitate the follow-up of patients in the trial. Where a patient had not responded to the follow-up questionnaire, the POPPI trial team contacted the patients GP practice to confirm or update contact details. The GP code was used by the POPPI trial team to enable the patient’s GP practice to be identified rapidly, and ensured follow-up was completed in a timely fashion.

Updated data was then added to the secure POPPI trial database, housed on the secure servers at Exponential-E, to ensure no contact was attempted with patients who have passed away. This section of secure database can only be accessed by ICNARC staff, using a unique username and password, who have been given permission to carry out the required duties on the POPPI trial.

Data collected from NHS Digital will be used only by a limited number of authorised individuals in the POPPI trial team who are employed by ICNARC with a legitimate need to use the data (i.e. sending the questionnaires and conducting analysis of the data).

Only substantive employees of ICNARC will access the data supplied by NHS Digital.

Nasstar employees have the ability to access NHS Digital data for logistical reasons however they will not access the data. Only authorised, substantive ICNARC employees will access NHS Digital data. All ICNARC employees are trained in data protection and confidentiality and have signed a contract, which incorporates a confidentiality clause and the consequences of breaching confidentiality are covered by disciplinary procedures. Data received from NHS Digital is stored on secure servers at ICNARC, hosted by Exponential-e with regular back-ups of the data. Exponential-e are compliant with ISO 9001; ISO 27001; ISO 14001; ISO 22301; ISO 50001; ISO 20000 and also hold a Health & Social Care Network Complaint certificate of compliance. Employees of Exponential-e will not access the data held under this agreement, but will provide storage/back-up, and as such, are listed as processors. Outputs from the study will contain only aggregate level data with small numbers suppressed in line with HES analysis guide.

ICNARC also contract Nasstar (formerly GCI Managed Services Ltd.) who provide external desktop and network managed services, including end user and infrastructure support. Employees at Nasstar will not access the data held under this agreement, however, they do have remote access to ICNARC servers (which are hosted by Exponential-e) and so are considered a Data Processor. Nasstar are compliant with ISO 20000-1:2011; ISO 27001:2013; ISO 9001:2015; Cyber Essentials Plus; and hold a Health & Social Care Network Complaint certificate of compliance.

Babble Cloud Limited will be replacing Nasstar on 1 June 2022, and will provide external desktop and network managed services, including end user and infrastructure support. Employees at Babble Cloud will not access the data held under this agreement, however, they will have remote access to ICNARC servers (which are hosted by Exponential-e) and [so are considered a Data Processor - Need to include statement to clarify why Babble not listed as DP - Anna?]. Babble Cloud Limited are registered under the DSP Toolkit (organisational reference: 8HP42) as ‘Standards Met’.

ICNARC will act to preserve patient confidentiality and will not disclose or reproduce any information by which patients could be identified. Data will not be used for commercial purposes, provided in record level form to any third party, and not used for direct marketing.

The output for the purpose of this request will be the cohort dataset with information about who has passed away and details of the GP practice for all members. This was used to enable the appropriate follow up questionnaire to be sent out to all living participants of the POPPI Trial.

The POPPI Trial database is now locked and primary dissemination of the trial results has completed. Dissemination and outputs thus far have included:

Publication of the clinical and cost-effectiveness results

The results of the POPPI trial were published in the Journal of the American Medical Association (JAMA) – a high-impact, widely read, peer-reviewed, international general medical journal.

The full reference for the results paper is as follows:

Wade, D.M., P.R. Mouncey, A. Richards-Belle, J. Wulff, D.A. Harrison, M.Z. Sadique, R.D. Grieve, L.M. Emerson, A.J. Mason, D. Aaronovitch, N. Als, C.R. Brewin, S.E. Harvey, D.C.J. Howell, N. Hudson, M.G. Mythen, D. Smyth, J. Weinman, J. Welch, C. Whitman, and K.M. Rowan, Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients: A Randomized Clinical Trial. JAMA, 2019. 321(7): p. 665-675.

Publication of the Final Report to the National Institute for Health Research (NIHR) Health Services and Delivery Research Programme

A comprehensive report of POPPI (which included a development (of the intervention phase), feasibility and piloting (two studies) and the cluster-RCT (which used data from NHS Digital)) was published in August 2019. Clinical trials funded by the NIHR are published in the open-access (free of charge) NIHR Journal's Library (http://www.journalslibrary.nihr.ac.uk/), meaning the results can be accessed by patients, carers, clinicians and researchers alike.

The full reference for the report is:

Mouncey PR, Wade D, Richards-Belle A, Sadique Z, Wulff J, Grieve R, et al. A nurse-led, preventive, psychological intervention to reduce PTSD symptom severity in critically ill patients: the POPPI feasibility study and cluster RCT. Health Serv Deliv Res 2019;7(30)

Publication of the Trial Protocol and Statistical and Health Economic Analysis Plan

As communicated previously, the Trial Protocol and Statistical and Health Economic Analysis Plan were published in February and January 2018, respectively. References are as follows:

Richards-Belle, A., P.R. Mouncey, D. Wade, C.R. Brewin, L.M. Emerson, R. Grieve, D.A. Harrison, S. Harvey, D. Howell, M. Mythen, Z. Sadique, D. Smyth, J. Weinman, J. Welch, and K.M. Rowan, Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): protocol for a cluster-randomised clinical trial of a complex intervention. BMJ Open, 2018. 8(2).

Wulff, J., Sadique, Z., Grieve, R., Howell, D., Mouncey, P., Wade, D., Rowan, K. M. Harrison, D. A. (2018). Psychological outcomes following a nurse-led preventative psychological intervention for critically ill patients trial: Statistical and health economic analysis plan. Journal of the Intensive Care Society, 19(4), 281–286. https://doi.org/10.1177/1751143718755016

Presentations at national and international conferences

To ensure the trial results are fed back to relevant national and international stakeholder groups, presentations have been conducted out at the following conferences thus far:

• European Society of Intensive Care Medicine - 31st Annual Congress (Paris, France)

• Intensive Care Society - State of the Art meeting (London, UK)

• Critical Care Reviews (Belfast, UK)

• Society of Critical Care Medicine - Annual Congress (San Diego, California, USA)

• Critical Care Symposium - 16th Annual Symposium (Manchester, UK)

• 10th Annual International Coference of The Saudi Critical Care Society (SCCS) (Riyadh, Saudi Arabia)

• Annual Meeting of the Case Mix Programme (London, UK)

• Annual NMAHP Conference (Cambridge, UK)

• 12th International Meeting of Physical Medicine & Rehab in the Critically Ill (Dallas, Texas, USA)

• American Thoracic Society (Dallas, Texas, USA)

• What's new in ICU? An informative day for AHPs & Nurses 11th Annual Meeting (Edinburgh, UK)

This dissemination plan is ensuring that the results of the trial are fed back to those delivering and organising care (e.g. nurses, doctors, managers) in the NHS (and across the world), allowing for any learning from the trial to influence clinical practice and the design of future research in this area. The trial results will also be available to patients and the public via the ICNARC website (www.icnarc.org) following expiration of the JAMA embargo period mentioned above.

[Note: It will not be/is not possible to identify any individual participating patient in any trial reports or presentations].

The main benefit for the data requested was to ensure that no further contact is made by the POPPI trial with participants who have passed away helping to ensure relatives are not caused undue stress by no longer appropriate contact. The database for the trial is locked and primary dissemination is completed (see ‘Outputs’ section). Secondary analysis of data may help to identify groups of patients who may benefit from the intervention and will further progress knowledge in treating patients in this vital area of critical care. Trial data need to be retained for a period of 10 years in line with the ICNARC Standard Operating Procedure.

The background to the trial is as follows:

Studies indicate high rates of serious psychological morbidity (e.g. post-traumatic stress disorder, anxiety and depression) amongst patients after their stay in a critical care unit. Early psychological assessment of risk and subsequent intervention/support are both key to reduce longer-term psychological morbidity. The Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI) cluster-randomised controlled trial sets out to inform the NHS on improving both access to, and delivery of, services to ensure that critically ill patients receive both psychological assessment and intervention/support in a cost-effective manner.

The POPPI complex intervention includes creating a more therapeutic environment for patients in the critical care unit, assessing consenting patients for acute psychological stress and, for those identified as acutely stressed, delivering three one to one stress support sessions (which are delivered by a specially trained POPPI nurse). ICNARC found that this intervention did not reduce patient-reported PTSD symptom severity for patients at six months post-recruitment – findings which do not support use of this intervention, allowing those organising and managing care to focus resources and for researchers and clinicians to design and study other psychological interventions. These results were published in February 2019 and primary dissemination for the trial has completed.

The POPPI Trial database is now locked and primary dissemination of the trial results has completed. As indicated in the ‘Outputs’ section, yielded benefits to date have included:

Publication of the clinical and cost-effectiveness results in the Journal of the American Medical Association (JAMA)

Publication of the Final Report to the National Institute for Health Research (NIHR) Health Services and Delivery Research Programme

The Trial Protocol and Statistical and Health Economic Analysis Plan have been published for public benefit.

Presentations at national and international conferences have been given to present the research and preliminary results.

As the results showed that it was not beneficial to have broadscale retraining of nurses to deliver psychological support to patients, this has not been implemented across the NHS.